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The World’s Leading Conference on ISO 9000 & Audits

Data Integrity Assessments - Why, When, How

Level: Intermediate

Keywords: Data Integrity, Assessment, Security

Industry: Not Industry Specific

Data integrity is one of those topics that we all think we understand. But do we?

It is beyond doubt extremely important for every company. Data integrity applies to all industries, data sources, and stores - laboratory, shop floor, automation, document control, and everywhere else.

There is an increased focus on data integrity across all industries and knowing how to determine where you stand can help you prevent issues such as regulatory findings, lost customer trust, inaccurate test results, decisions made on bad data, and much more.

Regulatory agencies such as the FDA have simply defined data Integrity as “The completeness, consistency, and accuracy of data”. Other sources include validity. In general, Data integrity is the accuracy, completeness, and quality of data as it’s maintained over time and across formats.

Preserving the integrity of your company’s data is a constant process. It’s worth noting that data integrity isn’t the same as data security, although the two concepts are related.During assessments, we get the inevitable push-back and long discussions such as “What is raw data?”, “That’s just for electronic data, right?”, and “What does data integrity governance look like?”

What does YOUR data integrity look like? What are the very necessary components of Data Integrity?

Several guidance documents can help, but taking a hard look, as in a semi-formal assessment, will reveal much and provide top management with the information needed to improve confidence in how company (or personal!) data is handled across the organization. A closer assessment of published guidance reveals that the design for data integrity must include both physical and logical components of data management. In many cases, the sheer volume and multiple platforms for collection and storage of data add previously unimagined complexity that needs to be addressed consistently.

This presentation will provide suggested approaches to assessing, improving, and monitoring data integrity, with emphasis on medical devices, and pharmaceutical or cosmetic manufacturing. The principles apply equally to any industry including clinical trials, government, aerospace, automotive, IT, or services. Among these industries and services, regulated or not, there are more similarities than differences in data handling. Although real names have been excluded from this presentation, real-life examples of excellent and not-so-excellent data integrity will be presented.


Nancy L. Pasquan

Principal, Eyes On, Inc., Escondido, CA, USA

Nancy is currently performing ISO certification, software and GxP supplier audits across a wide range of manufacturers and service providers.

She has over 30 years of experience in software systems development, maintenance, and management on pharmaceutical, medical device, clinical, military, and commercial projects.

She spent years providing computer system validation services and training to medical device and pharmaceutical companies.

She holds a BS in Computer Science, is past Treasurer and Secretary of the ASQ Software Division, past treasurer of the San Diego section (703), and served on the San Diego chapter of the Society for Software Quality (SSQ) board.

Nancy travels whenever the opportunity arises and can otherwise be found wandering around in the San Diego sunshine.

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